ISO Standards based

Ventilator Terminology
Steven Dain MD FRCPC
Associate Adjunct Professor, Electrical and Computer Engineering,
University of Waterloo, Waterloo, Ontario, Canada
Anesthesiologist, Woodstock Hospital, Woodstock, Ontario Canada
Chair, ISO TC 121, SC4 Vocabulary and Semantics
Current State
 ISO TC 121 SC4
• Anesthesia and Respiratory Care—
Terminology and Semantics
• Requested by ISO TC121/IEC62D JWG Critical
care ventilators to devise a terminology for all
ventilators in January 2009
• Chair: Steven Dain MD
• Secretary: Ken Ledez MD
• Project Manager: Norman Jones PhD
 Process
• Scientific and medical literature review
• Collection and review of current ventilator
manuals (over 30) and marketing material
• Review of MAUDE reports
• Informal discussions and surveys with
Anesthesiologists, Intensive Care Physicians,
Respiratory Therapists, RT Educators,
Manufacturer’s R&D and marketing
 Conclusions
• It’s a mess
• Need to establish the conceptual framework
that underlies advanced artificial ventilation
• Need to test currently used terminology
against that framework
• Need to cooperate with other SDO’s to have
all related standards using consistent terms
 Objectives
• Need to start from first principles and create a
patient-focused terminology with the patient
seen as an independent active system
• Need to clearly delineate between:
– settings (intent) → what you want the
ventilator to do and how you want it to
respond to the patient
– observations of what really happened to the
patient and ventilator system of systems
(maybe non-deterministic based on settings)
Any material presented after
this point is subject to change
ISO 19223 Lung ventilators and related
equipment—Vocabulary and semantics
Scope
This International Standard specifies vocabulary and semantics for all
fields of respiratory care such as Intensive care ventilation, anaesthesia
ventilation, and home care ventilation including sleep apnoea
breathing therapy equipment, emergency and transport ventilation,
that may be used:
– in lung ventilator and breathing therapy device standards
– in health informatics standards
– for labelling on me equipment and me systems
– in me equipment and me systems instructions for use and
accompanying documents
– for me equipment and me systems interoperability
– in electronic health records
 “We needed to find words to describe clearly the detailed
interaction of a baby with the ventilator” We then realized the
serious problems with the terminology used for ventilation and
resuscitation. If we wrote about breaths, it was not clear to the
reader whether this referred to the baby breathing or inflations
by the ventilator…”

Arch Dis Child Fetal Neonatal Ed 2012;0:F1–F3. doi:10.1136/archdischild-2012-302137

 Inflation
<setting> application of a ventilator-generated
elevated pressure to the patient-connection
port, with the intention of causing an increased
volume of gas in the lung
 Spontaneous Breath
• This term has been the most contentious issue
in development of ISO 19223
• Consensus definition after much discussion

Spontaneous Breath
breath initiated by the patient
*This has ramifications when calculating rate
 Spontaneous Breath Rate
• Number of spontaneous breaths per minute.
• Measure of the respiratory drive of the
patient, which cannot be currently
determined with the current terminology
 Mandatory Inflation
Dictionary definition
mandatory
required to occur

Mandatory inflation
<setting> inflation that is assured to be initiated
or instigated at the set rate
 Diagram showing the concepts of the relationship
Spontaneous between breath and inflation related terms in ISO
inspiratory terminology
activity

Patient
Patient trigger Support
demand inflation
flow
Patient
trigger
Unassisted
1
Primary
inflation

Assisted
Cause of initiation
Ventilator
Breath Supported
initiation Outcome

2
Scheduled
Controlled
Unscheduled

Ventilator
generated function

1 or 2 can occur as separate breaths concurrently with a primary inflation if this is of the ePC type.
1 or 2 can occur as separate breaths concurrently with a primary inflation cycle in Group (ii) modes NSJ Iss4:11/9/2014
 Mode Patterns
• Mode pattern 1
– One inflation type generating a controlled or assisted
breath, on a set baseline airway pressure level
• Mode Pattern 2
– One or more inflation types, primary inflation assured to
be delivered at set rate; patient is free to breathe between
primary inflations, unassisted or supported by a support
inflation, on a set baseline airway pressure level
• Mode Pattern 3
– Spontaneous breathing with one support inflation-type, or
unassisted, on a set baseline airway pressure level
 Inflation Types
• Flow control (volume control)
• Pressure control
• Enhanced pressure control
• Volume-targeted pressure control
• Proportional pressure control
• Pressure support
• Proportional pressure support
• Dual control e.g., VC/PC
 PEEP CPAP Bilevel
• What is PEEP?
• Is it a measurement?
• Is it a setting?
• Is it both?
• Then what is CPAP?
• What do you call the levels of bilevel?
• I’m very confused……..
 Baseline Airway Pressure (BAP)
<setting> setting for the intended minimum
pressure in the alveoli during the exhalation
phase
 End Exhalation Pressure (EEP)
• <observation> airway pressure at the end of
an exhalation phase
• is a measurement only, not a setting
• can be zero
• could be negative
 Ventilator Mode
• specified manner in which a ventilator
performs its function when connected to a
patient
• Includes:
– mode group pattern
– inflation types
– breath types
– baseline airway pressure
– extras -- e.g., tube compensation
 Representation of a typical SIMV-ePC/PS waveform
over 1 minute, illustrating respiratory rate terminology
S S S S S

pAW

P-T P-T P-T P-T P-T P-T V P-T P-T P-T P-T P-T V P-T P-T P-T P-T V P-T P-T

P-T patient-trigger initiation of inflation (following detection of patient initiation of spontaneous breath)
V ventilator initiation of inflation
S patient initiation of unassisted spontaneous breath

Standardised Term Type of respiratory feature counted Value

ventilator set rate (setting) 7
ventilator-initiated inflation rate Time initiated ePC inflation 3
patient-triggered primary-inflation rate Patient-triggered ePC inflations 4
unassisted (spontaneous) breath rate Unassisted spontaneous breaths 5
patient-triggered inflation rate Patient-triggered ePC+PS inflations 17
patient-triggered support-inflation rate Patient-triggered PS inflations 13
(total) inflation rate Sum of all ePC and PS inflations 20
spontaneous breath rate Spontaneous inspiratory breaths taken by patient 22
patient-triggered concurrent-inflation rate Patient-triggered concurrent inflations NA
unassisted concurrent-breath rate Unassisted concurrent spontaneous breaths 5
total respiratory rate All respiratory cycles 25
unassisted & supported breath rate Unassisted breaths + support inflations 18
A B C D E F G H I J K L M N O P Q R
Optional 'bi- Name of Set Value Name of Name & Symbol for
Basic Generic Illustrative Inflation Means of Spontaneous- level' for Inflation Type Set Name & Symbol of Set Lower Baseline-
Mode Mode-Group Types Selected for Means of Means of Exhalation support Corresponding Superordinate Selected for baseline Name of Primary Set Primary Inflation airway-pressure
Ident No. Class Name Mandatory Delivery Initiation Termination Control Inflation Type Mode Name Class Name Mandatory Delivery level Inflation Phase Time Time (if set)

4 1 (i) CMV VC t t See commentNone CMV-VC N/A Tidal volume BAP Inflation phase Inflation time tI Expiratory time t E
5 2 PC t t " None CMV-PC N/A Inflation pressure BAP Inflation phase Inflation time tI Expiratory time t E
6 3 vtPC t t " None CMV-vtPC N/A Tidal volume BAP Inflation phase Inflation time tI Expiratory time t E
7 4 e PC t t " None CMV-e PC CMV bi-level Inflation pressure BAP Inflation phase Inflation time tI Expiratory time t E
8 5 vte PC t t " None CMV-vte PC CMV bi-level Tidal volume BAP Inflation phase Inflation time tI Expiratory time t E
9
10 6 A/MV aka A/C VC t/trig t " None A/C-VC N/A Tidal volume BAP Inflation phase Inflation time tI Expiratory time t E
11 7 aka A/C PC t/trig t " None A/C-PC N/A Inflation pressure BAP Inflation phase Inflation time tI Expiratory time t E
12 8 aka A/C vtPC t/trig t " None A/C-vtPC N/A Tidal volume BAP Inflation phase Inflation time tI Expiratory time t E
13 9 aka S/T PC[q/t] t/trig q/t " None A/C-e PC[q/t] N/A Inflation Pressure BAP Inflation phase Inflation time tI Expiratory time t E
14 10 aka A/C e PC t/trig t " None A/C-e PC A/C bi-level Inflation Pressure BAP Inflation phase Inflation time tI Expiratory time t E
15 11 aka A/C vte PC t/trig t " None A/C-vte PC A/C bi-level Tidal volume BAP Inflation phase Inflation time tI Expiratory time t E
16 12 aka A/C e PC[S] t/trig [S] " None A/C-e PC[S] A/C bi-level BAPH (or p H) BAP BAPH phase(or p L) BAPH (phase)time t H BAP time tL
17
18 13 (ii) IMV VC t t " PS IMV-VC/PS N/A Tidal volume BAP Inflation phase Inflation time tI Expiratory time t E
19 14 PC t t " PS IMV-PC/PS N/A Inflation Pressure BAP Inflation phase Inflation time tI Expiratory time t E
20 15 vtPC t t " PS IMV-vtPC/PS N/A Tidal volume BAP Inflation phase Inflation time tI Expiratory time t E
21 16 e PC t t " PS IMV-e PC/PS IMV bi-level Inflation Pressure BAP Inflation phase Inflation time tI Expiratory time t E
17 e PC t t PS IMV-e PC IMV bi-level BAPH (or p H) BAP BAPH phase(or p L ) BAPH phase time t H BAP time tL
"
22 aka APRV
23 18 vte PC t t " PS IMV-vte PC/PS IMV bi-level Inflation Pressure BAP Inflation phase Inflation time tI Expiratory time t E
24 19 e PC[S] t [S] " PS IMV-e PC[S]/PS IMV bi-level BAPH (or p H) BAP BAPH phase(or p L) BAPH (phase)time t H BAP time tL
20 e PC[S] t [S] PS IMV-e PC[S] IMV bi-level BAPH (or p H) BAP BAPH phase(or p L) BAPH (phase)time t H BAP time tL
"
25 aka APRV
26
27 21 SIMV VC [S]t t " PS SIMV-VC/PS N/A Tidal volume BAP Inflation phase Inspiratory time t I Expiratory time t E
28 22 PC [S]t t " PS SIMV-PC/PS N/A Inflation pressure BAP Inflation phase Inspiratory time t I Expiratory time t E
29 23 vtPC [S]t t " PS SIMV-vte PC/PS N/A Tidal volume BAP Inflation phase Inspiratory time t I Expiratory time t E
30 24 e PC [S]t t " PS SIMV-e PC/PS SIMV bi-level Inflation Pressure BAP Inflation phase Inspiratory time t I Expiratory time t E
31 25 vte PC [S]t t " PS SIMV-vte PC/PS SIMV bi-level Tidal volume BAP Inflation phase Inspiratory time t I Expiratory time t E
26 e PC[S] [S]t [S] PS SIMV-e PC[S]/PS SIMV bi-level BAPH (or p H) BAP BAPH phase BAPH(phase)time t H BAP time tL
"
32 aka Bi-level
33
34 27 (iii) CSV aka SPONT None N/A N/A " PS CSV-PS N/A N/A BAP N/A N/A N/A
35 28 aka SPONT None N/A N/A " pPS CSV-PS N/A N/A BAP N/A N/A N/A
36 29 aka SPONT None N/A N/A " vtPS CSV-vtPS N/A N/A BAP N/A N/A N/A
37 31 aka CPAP None N/A N/A " None CSV N/A N/A BAP N/A N/A N/A

Modes on rows of this color all come under the general superordinate classification of 'bi-level' but the name NSJ v10
'Bi-level' is normally only used as the primary classification for mode Ident No 26 11-Feb-14
 Multi SDO Cooperation
• IEEE 11073 Committee
• ISO TC215 Health Informatics
• IHE (Integrating the Health Enterprise) PCD
• International Healthcare Terminology
Standards Development Organization
Anesthesia Special Interest Group
– SNOMED CT
• HL7 Anesthesia Special Interest Group
 Summary
• still a work in progress
• concurrently writing a handbook to facilitate
the understanding of the standard
• Draft International Standard (DIS) will be out
for ballot June 2015 depending on time for
translation
 Thanks to

Norman Jones PhD Warren Sanborn PhD Manfred Bier

Jan Wittenber Paul Schluter PhD Debra Milamed MLS
John Walsh MD Go Hirabayashi MD Mikael Dahlke
Ken Ledez MD Ken Fuchs MEng Paul Dixon PhD
Dieter Weismann PhD Ken Marks RRT Colin Morley MD
John Hedley-Whyte MD Cyndi Miller RRT David Scott MD
Dave Osborn Julian Goldman MD Greg Dockar RRT
Andrew Norton MD Rob Chatburn RRT Chris Thompson MD
Terri Monk MD Fernando Isaza Akito Ohmura MD
Covidien Draeger GE
Phillips/Respironics Maquet ResMed
Many more